臨床研究等提出・公開システム

A Phase 3 Randomized Double Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell (BGB-11417-302)

A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adult Patients With Relapsed/Refractory Mantle Cell

Takahashi Kimi

BeOne Medicines Japan

Shiodome City Center, 1-5-2 Higashi-Shimbashi, Minato-ku, Tokyo

MedInfoJP@beigene.com

Hamano Fumiaki

BeOne Medicines Japan

Shiodome City Center, 1-5-2 Higashi-Shimbashi, Minato-ku, Tokyo

+81-800-919-0351

MedInfoJP@beigene.com

Recruiting

May. 23, 2025

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

1. Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
2. Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
3. Relapsed or refractory disease after the last line of therapy
4. Measurable disease is defined as at least one nodal lesion with a longest diameter greater than 1.5 cm, or at least one extranodal lesion with a longest diameter greater than 1 cm.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
6. Adequate organ function

1. Prior therapy with B-cell lymphoma-2 inhibitor
2. Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi
3. Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
4. Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
5. Known central nervous system involvement by lymphoma
6. Clinically significant cardiovascular disease
7. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Both

relapsed/refractory mantle cell lymphoma

Eligible patients will be randomized in a 1 to 1 ratio to receive either sonrotoclax plus zanubrutinib [Arm A] or sonrotoclax matched placebo plus zanubrutinib [Arm B].

Arm A
Starting Cycle 1 Day 1, zanubrutinib will be administered at 320 mg once daily or 160 mg twice daily until progressive disease, unacceptable toxicity, or meeting any other treatment discontinuation criteria.
On Cycle 2 Day 1, patients will initiate sonrotoclax once daily based on the twice a week ramp-up schedule until the target dose of 320 mg is reached, which will continue until the end of Cycle 27. One cycle is defined as 28 days.

Arm B
Starting Cycle 1 Day 1, zanubrutinib will be administered at 320 mg once daily or 160 mg twice daily until progressive disease, unacceptable toxicity, or meeting any other treatment discontinuation criteria.
On Cycle 2 Day 1, patients will initiate sonrotoclax matched placebo once daily based on the twice a week ramp up schedule until reaching the equaled target dose of 320 mg of sonrotoclax.
Patients will continue sonrotoclax matched placebo until the end of Cycle 27. One cycle is defined as 28 days.

PFS, as assessed by BIRC, defined as the time from randomization to the date of progression or death, whichever occurs first.

+81-43-264-5431

April. 16, 2025

No

United States/Argentina/Australia/Brazil/China/France/Germany/Italy/Korea/New Zealand/Poland/Puerto Rico/Spain/Turkey/United Kingdom/Austria